Comparison of the effect of ketorolac and intravenous lidocaine on fentanyl-induced cough in patients undergoing elective surgery: a Double-blind clinical trial

The aim of this study is to evaluate the efficacy of ketorolac in inhibiting the fentanyl induced cough of before induction of general anesthesia and to compare its effectiveness with intravenous lidocaine so that it can be used as an alternative when lidocaine is contraindicated.

prospective randomized controlled trial with control group, 3 arm parallel groups, double-blind, randomized, phase 3 on 210 patients. Excel software rand function was used for randomization.

in Firoozgar and Rasool Akram Hospital Eligible patients are randomly assigned to one of three groups receiving intravenous lidocaine, ketorolac, or normal saline.Depending on the group of each patient, drugs of the same volume will be injected and then receive intravenous fentanyl and the incidence and severity of the cough will be recorded.

The patients are 18 to 60 years old, with any gender and with ASA 1 or 2, who referred to Firoozgar and Hazrat Rasool Akram hospitals in the period of April 2022 to June 2022 and are candidates for elective surgery that lasts more than an hour. Exclusion criteria are: preoperative pulmonary emphysema, bronchial asthma, history of upper respiratory tract infection over the past 2 weeks, smoking, history of hypertension and coronary artery disease, chronic cough, hypertension Inside the eye, brain or abdomen, etc...

Depending on the group of patients, 0.5 mg / kg ketorolac, 1 mg / kg lidocaine or normal saline is injected intravenously in the same syringe with the same volume within 15 seconds. After 3 minutes of drug injection, all patients will receive 3mcg / kg intravenous fentanyl within 3 seconds. The occurrence and severity of cough will be recorded.

Cough, Cough intensity, Cough onset time, Heart rate, Arterial blood pressure, Arterial oxygen saturation

Patients randomly (using the computer random numbers method which, the numbers 1 to 3 are entered into the computer and by pressing the button to create a random number, a number between 1, 2 and 3 is generated that will indicate the patient group) enter In one of the 3 groups receiving intravenous lidocaine, ketorolac or normal saline are included as placebo until the sample volume is completed.

After selecting patients to enter the study, patients are randomly assigned to one of the 3 groups receiving intravenous lidocaine, ketorolac or normal saline as a placebo to complete the sample size. These individuals are in groups A, B, C The group of each patient is written in a sealed envelope and is given to each person in the unit before the operating room by the researcher and the patient enters the operating room with it. The drugs are prepared in similar 5 cc syringes by an anesthetist of the recovery unit who has no role in patient care and the names of the groups are labeled on them. Upon entering the room, the anesthesiologist in the room delivers the medication to the assistant along with the other anesthetics to induce anesthesia. The patient enters the study after obtaining consent and according to the information given about the study, but does not know about the injectable drug. In this way, patients and drug injecting assistants and cough observers (who are responsible for recording data) will be unaware of prescription drugs and study grouping

Due to the publication of the results completely, there is no need to publish the research data separately. Also, in this study, consent is not obtained to use patients' data in other studies, which is another reason that justifies this issue.

All the data of this research, including variables and primary and secondary consequences, etc., can be shared without naming people.

From the time the results are published, all information will be available without time limit.

Information will be available to all academic and non-academic researchers in any field.

Patients' data will not be published separately, and other studies must use a code of ethics to use this information and, after consulting the contributors to the present study, obtain their consent again.

Sara Tahzibi Contact No. : 00989192419907 E-mail: Sara.tahzbi@gmail.com

Obtaining ethics - Obtaining written permission from the collectors of the present study - Obtaining re-consent from the patients present in this study to use their information